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Medical Device Product Development: An Ecosystem

Medical device product development is changing. Along with the increasing complexity and strict regulatory requirements such as ISO 13485 compliant product development, comes the evolving need to expand the capabilities of products to include enablement for the Internet of Things. These changing specifications place additional demands on the chosen outsourced development partner. The partner must have the capabilities not only to deliver hardware, software, embedded programming, and vision capabilities but also, web, cloud, and mobile development expertise.

To find a single provider that not only delivers all of these capabilities but delivers them at a depth necessary to complete the project successfully is a challenge. Partners with strong industrial design teams may lack skills in embedded hardware, software or vision. Web design firms may be able to deliver the mobile app but will likely struggle with device development and connectivity.

In our years of medical device product development, Resolution has learned that the best development approach involves a partnership of best of breed providers, each bringing their specific levels of skill across the key areas of product development. The industrial design team works on creating the best design for usability and the market. The product development team works on embedded hardware, software, vision, etc., to create a functional, manufacturable product. The mobile, web and application development team securely connects the product to the Internet of Things and cloud-based technologies. Throughout the project, all the partners adhere to standards such as ISO 13485 compliant product development across a rigorous quality management process. The process also ensures compliance with IEC 60601 (Safety and Performance), ISO 14971 (Risk Management) and IEC 62304 (Software Lifecycle). We call this combination the Resolution Development Ecosystem.

What makes the Resolution Development Ecosystem unique is the level of interaction and accountability. The partner relationship is such that you have a single point of contact for any issues or changes. While you get the depth of capabilities, you only need to speak to a single contact. In addition, when you need to speak directly to an engineer, he or she will be available. There is not cumbersome hierarchy or infrastructure to navigate to get your question answered or request addressed.

Medical device product development will continue to evolve. Your customers will want new and innovative approaches to patient care while still strictly focusing on patient safety and privacy, along with ISO 13485 compliant product development and other regulatory compliance.